Non-Small Cell Lung Cancer Clinical Trial
— COMBINATIONOfficial title:
Combining Afatinib and Concurrent Chemotherapy, Followed by Osimertinib and Concurrent Chemotherapy, in Untreated EGFR Positive NSCLC Tumors
The aim of the COMBINATION trial is to prospectively study the sequential approach of using afatinib combined with a short course of chemotherapy, followed by osimertinib, upon progression and acquisition of a T790M mutation, also combined with a short course of chemotherapy.
Status | Recruiting |
Enrollment | 21 |
Est. completion date | January 2025 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Histologically confirmed NSCLC, positive for non-exon20insertion uncommon EGFR mutations that are eligible for afatinib therapy in first line 2. WHO PS 0-2 3. Be willing and able to provide written informed consent for the trial. 4. Be above 18 years of age on day of signing informed consent. 5. Patients must have radiological measurable disease 6. Demonstrate adequate organ function, as deemed acceptable by the treating physician in the context of metastatic NSCLC. Exclusion Criteria: 1. Inability to provide informed consent 2. Inability to take study medications 3. Patients with symptomatic or unstable CNS metastases 4. Prior EGFR TKI or platinum-doublet therapy for advanced stage NSCLC. Prior (neo)adjuvant treatments are allowed when the last administration is one year or more. 5. Evidence of interstitial lung disease or active, non-infectious pneumonitis. 6. Active infection requiring systemic therapy. 7. Active Hepatitis B or C. 8. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 9. Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the screening visit. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam UMC, location VUmc | Amsterdam | Noord-Holland |
Lead Sponsor | Collaborator |
---|---|
Amsterdam UMC, location VUmc |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease control rate (DCR) | To assess the efficacy of the sequential strategy of front-line afatinib-chemo, followed by a treatment with osimertinib-chemo in those patients that develop a T790M mutation as a mechanism of resistance | 18 months | |
Secondary | Progression Free Survival (PFS) | To assess long term efficacy | From start of therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 50 months | |
Secondary | Overall Survival (OS) | To assess long term efficacy | From start of therapy until the date of death from any cause, assessed up to 50 months | |
Secondary | Objective response rate according to RECIST v1.1 after start of afatinib | To assess short term efficacy | At 6 weeks | |
Secondary | Objective response rate according to RECIST v1.1 after start of afatinib | To assess short term efficacy | At 12 weeks | |
Secondary | Objective response rate according to RECIST v1.1 after start of osimertinib | To assess short term efficacy | At 6 weeks | |
Secondary | Objective response rate according to RECIST v1.1 after start of osimertinib | To assess short term efficacy | At 12 weeks | |
Secondary | Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | To assess the safety of afatinib and osimertinib intercalated with 2 cycles of carboplatin-pemetrexed | From start of therapy until disease progression or study drug toxicity assessed up to 100 days after part 1 and 2 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03087448 -
Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1 | |
Recruiting |
NCT05042375 -
A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Terminated |
NCT05414123 -
A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
|
||
Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
Recruiting |
NCT05919537 -
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
|
Phase 1 | |
Recruiting |
NCT05009836 -
Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
|
Phase 3 | |
Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03219970 -
Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
|
||
Recruiting |
NCT05949619 -
A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04054531 -
Study of KN046 With Chemotherapy in First Line Advanced NSCLC
|
Phase 2 | |
Withdrawn |
NCT03519958 -
Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
|
||
Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
Terminated |
NCT02580708 -
Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01871805 -
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1/Phase 2 | |
Terminated |
NCT04042480 -
A Study of SGN-CD228A in Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05919641 -
LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
|
||
Completed |
NCT03656705 -
CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma
|
Phase 1 |